New advice on cannabinoid limits in cannabis consumer products in the UK are welcome but slow, with more clarification needed, industry members have said.
On Friday, 17 December the Advisory Council on the Misuse of Drugs (ACMD) issued a report with new recommendations for the appropriate levels of cannabinoids contained in consumer CBD products.
The development followed a statement from the Home Office in January 2021 announcing its intention to establish a legal framework for the products.
The resulting report has recommended that a new limit of 0.5 milligrammes of THC can now be contained in products – “per serving”. This is a welcome development for the industry from the current 0.2 to 0.3 milligramme allowance “per container”, however, industry experts have said that new and sensible regulations are developing slowly.
“In many ways this is a good report and the science is thorough and clear. The first conclusion is that they considered that the lowest dose of THC that would produce any adverse effect is 2 to 5 milligrammes per day,” said medical cannabis expert, professor Mike Barnes, chair of the UK’s Cannabis Industry Council.
“They then arbitrarily reduced this to 1 milligrammes THC which “was unlikely to produce significant psychoactive effects”. Oddly they then add “uncertainty” factors of 10 fold to allow for differences in age, body size, individual variation in response (with no back-up evidence) and then further reduce that by another factor of 2 to “take account of variations in use or concurrent use of more than one product”.”
Barnes highlights that the new guidance gives CBD sellers the ability to sell bigger containers without breaching the limits, something that has been hindering the industry in the UK for a number of years.
“Thus they reduce the 1 milligramme by 20 times to make a “safe” amount of THC of just 50 micrograms per “serving”. The definition of serving is open to interpretation – “the typical quantity consumed on one occasion”. So where does this get us?
“Certainly, this would provide more sensible regulation than the existing “1mg per container” rule. A container, for example, with 20 servings would still contain 1mg THC whereas one with 40 servings would contain 2mgs THC.
“This would allow producers to sell larger containers without breaching the limit. Some progress – but still the allowed level of THC is ridiculously small when the report admits that 2 to 5 milligrammes THC per day would not produce adverse effects. We inch by inch head towards sensible regulations but oh so slow.”
Director for the regulatory and compliance unit at the Association for the Cannabinoid Industry (ACI) Dr Parveen Bhatarah, who consulted on the report, also welcomed the news, but highlighted that more clarity is needed.
Writing to the Home Office, Bhatarah said that the guidance was “Certainly a step in the right direction” but that the limit guidance “is a little bit confusing for the industry” and “more clarity is needed as it is open to miss interpretation without maximum daily dose.”
Bhatarah commented: “However, I do agree that they are also combining it with a maximum daily dose of CBD.
“I’ve been saying to the Home Office that if we want a sustainable CBD industry, we need to give incentive to the companies to have a much more economical process.
“So, analytical testing needs to be sorted and manufacturing needs to be a little bit cheaper because if you are having such a tighter regulation for the THC that means companies have to purify material a lot more, and hence, lower yield, and hence more cost for the industry to produce that material.
“I’m really, really pleased I must say that they have gone far beyond what I was expecting.”
Italy passes decree that could put CBD farmers at risk of jail
Marco Perduca of Associazione Luca Coscioni says the decree puts Italy’s entire supply chain at risk.
Italy has passed a decree that prohibits the cultivation of CBD crops without authorisation from the country’s Ministry of Health.
CBD cultivation has been legal in Italy since 2016 after a unanimous vote in parliament. However, this month the Conference of State and Regions adopted a Ministerial Decree which now prohibits the crop’s cultivation.
Farmers, which until have been allowed to grow crops containing a limit of 0.2 to 0.5 per cent THC, will only be able to cultivate hemp crops unless given authorisation from the Ministry of Health. The ruling mirrors the current law surrounding the cultivation of higher THC cannabis crops for medical purposes.
With CBD available in shops across the country, the move is one in complete contrast to the direction of the rest of Europe, bar France, which recently passed a decree banning the sale of CBD flowers to consumers.
It will also put the entirety of Italy’s CBD supply chain at risk, says president of Italy’s cannabis referendum committee ReferendumCannabis and co-founder of Associazione Luca Coscioni, Marco Perduca.
Speaking to Cannabis Wealth, Perduca commented: “This has always been in the back of the centre right’s mind.
“The Ministerial Decree which is another vehicle to make law – even if it’s more on the administrative rather than and the lawmaking level – in which they re-included plans for reducing CBD under the regular rules set by the text on all drugs.”
“This will imply for those already in the business and the newcomers, to seek a permit from the Ministry of Health, which per se will not be a problem. But why would you have to ask, or re-ask permission for a well-established enterprise, to a ministry that has nothing to do with the oils, soaps and edibles that are produced using some CBD and a very minimal percentage of THC?”
Perduca highlights a debate is set with the president of the Agriculture Committee on the matter.
“It’s an interpretation of the law. It is not opinion-makers that make interpretations of the law – it is a judge. So, if you have the police that come to your shop, or to your house or to your farm and would like to know more on what you are producing or selling, they can confiscate everything and block your activity until further notice.
“This is an additional burden on an already not-working system of justice. It is also a sort of CBD scare that has been launched against in particular shops and entrepreneurs – about 10,000 people that work in 3000 Small and Medium Enterprises which generate around €40m per year.
“It’s an important part of our agricultural economy, and it’s mainly young people that invest in these kinds of enterprises.’
Together with Leonardo Fiorentini, member of Forum Droghe, Perduca stated that the discussion of the decree took place days following the first meeting between the Ministry of Health and the country’s cannabis patient associations to discuss supply requirements.
They stated: “The version in front of the delegates risks canceling, if not sending to jail, the entire cannabis light [CBD] sector in Italy…
“The World Health Organization has repeatedly recommended the exclusion of the properties of CBD from banned substances, some of these were collected by the UN Drugs Commission which in December 2020 canceled cannabis from the IV table of the 1961 Convention with a vote favourable of Italy.
“To insert this submission of production to the rules of 309/90 with a Ministerial Decree, as well as going against common sense, is legally very questionable. Certainly, we need a regulation that clarifies what it can be cultivated and how to guarantee the quantity and quality of therapeutic cannabinoids necessary to guarantee the therapeutic plans of tens of thousands of people: products with a certain threshold of CBD must be treated as drugs, those below as supplements, as is already the case today for many other substances also in other EU states.
“We appeal to the competent Ministers to amend the Decree to art. 1 paragraph 4. If not, we will organize a coordinated response between patients and entrepreneurs to definitively send anti-scientific and ideological measures to the attic.” [translated from Google]
CBD-brand MYO launches in Boots across the UK
MYO will be available in 838 Boots stores across the country.
CBD-brand MYO has hit a major milestone in its journey with a new partnership that will see its products stocked in the leading UK health and beauty retailer’s stores.
Boots will stock MYO‘s Plant Proteins in 838 stores, branched-chain amino acids and essential amino acids in up to 574 stores, and functional sprays in 522 stores.
MYO, acquired by global vertically integrated wellness platform Yooma Wellness in March 2021, is one of the few brands whose CBD products have passed the UK Food Standard Agency’s (FSA) validation assessment.
James Lawson Baker, Founder of MYO Plant Nutrition, commented: “This is a major milestone for MYO and we are absolutely delighted to be partnering with Boots, the leading health and beauty retailer in the UK.
“A listing of this size gives the brand enormous national exposure and deepens our footprint within mainstream UK retail.
“The listing will support MYO in making plant-based active nutrition and wellness products mainstream and accessible.
“The partnership is a testament to the high-quality product and brand offering that we have built over the past year. We look forward to building our credibility amongst Boots’ customers going forward.”
The product listing with Boots adds to its list of retail chains where its products are available, including Holland & Barrett, Selfridges, Lloyds Pharmacy and Amazon.
Jordan Greenberg, CEO of Yooma, commented: “MYO Plant Nutrition is an exceptional example of how Yooma’s buy-and-build strategy creates shareholder value.
“MYO continues to surpass expectations with its increased availability in UK’s most reputable retailers and it has the honour of being known as one of the few brands to have passed the FSA’s validation assessment.”
British Cannabis celebrate products receiving confirmation from FSA
British Cannabis is dedicated to ensuring the long-term continuity of cannabis-based food supplements in the UK
British Cannabis products receive confirmation of being the first Cannabis-derived CBD oils and supplements set to remain on the market
British Cannabis™, registered as CBD Health Foods Ltd, is delighted to become the first company to receive confirmation from the Food Standards Agency UK (FSA). that its cannabis-derived products will remain on the market.
On Thursday 13th January 2022, the FSA confirmed via emails to British Cannabis CEO, Thomas Whettem, that the evidence submitted in support of 15 dossiers, spanning over 3,000 products “has been checked and is sufficient” and that “the public list will be amended to reflect these changes”.
Meanwhile, it is widely speculated that an as-yet-undetermined number of other products, made by other manufacturers, will be removed from shelves by Trading Standards. This process looks set to begin once the FSA public lists are updated later in 2022.
British Cannabis products
Robert Jappie, the partner at legal firm Ince and preeminent cannabis industry lawyer, remarked at the news: “I’m delighted that British Cannabis has received a positive response from the FSA to their Novel Food submission. Admission of British Cannabis’ products to the compliance registers confirms the company’s position at the forefront of the U.K. CBD industry. Novel Food compliance should now provide a platform for the sector to build on its fantastic success to date.”
Over the course of 18 months and a multi-million-pound investment, British Cannabis, whose brands are stocked across many pharmacies and retailers internationally, have dedicated themselves to ensuring the long-term continuity of all-natural, cannabis-based food supplements in the UK. This is for the reassurance of their own consumers and of all the customers whose brands are powered by British Cannabis.
Making this achievement of particular note is the fact that British Cannabis products are among the few remaining on the market to use ‘100 per cent Cannabis sativa L.”, naturally derived formulas, thus they contain the hundreds of clinically proven plant phytochemicals found in cannabis, whilst also being 0 per cent THC, meaning that they will not cause a “high”. Their food supplements (CBD oils, capsules etc.) are also free from other controlled cannabinoids.
British Cannabis’ CEO, Thomas Whettem, reacted shortly after hearing the great news: “Confirmation directly from the Food Standards Agency, that British Cannabis will be the first manufacturer In the world to have cannabis-derived consumer products ratified by the UK government, is yet another monumental breakthrough in our history. For years we have not just pioneered change in this industry but strived to set the bar when it comes to compliance, safety and the simple dedication to excellence we have had since day one.”
British Cannabis’ Managing Director, David Ralson, commented on this landmark news: “This is a huge milestone for our business and the Cannabis industry as a whole. I would firstly like to pay testimony to our staff, who over the past 6 years have endeavoured to make British Cannabis the leading legal-cannabis experts in our sector and this exemplifies our phrase ‘’We Know More Because We Do More’’.
We have always believed in wholly cannabis-derived, natural products and obtaining the highest quality standards. This is underpinned by our own retail brands, which to date have received over 4,200 Trustpilot reviews with a 5-Star rating.
This also paves the way for our trusted white label partners brands, who continue to work with us, to also remain on the UK market. This allows our business and its compliant partners to continue to grow in what is going to be a very exciting year indeed.”
At the time of release, the Novel Foods public lists have yet to be updated.